Automatic reconstitution for dual chamber syringe

• US 9,821,118 B2
• Filed: 08/30/2012
• Issued: 11/21/2017
• Est. Priority Date: 09/02/2011
• Status: Active Grant

• Current Assignee: UNL Holdings, LLC
• Original Assignee: UNL Holdings, LLC
• Inventors: Adlon, Katlin M., Weaver, Philip A., Dungar, Peter J.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Legette-Thompson, Tiffany
• Application Number:
  US13/599,013
• Publication Number:
  US 20130060232A1
• Time in Patent Office: 1,909 Days
• Field of Search: 604 45, 604 82- 92, 604122, 604124-129, 604181, 604192, 604506, 604518, 604187, 604136, 604228, 206219-221
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/3132 having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
• CPC Class Codes: A61M 2005/31598 having multiple telescopically sliding coaxial pistons encompassing volumes for components to be mixed
• CPC Class Codes: A61M 2005/3231 Proximal end of needle captured or embedded inside piston head, e.g. by friction or hooks
• CPC Class Codes: A61M 2005/3241 Needle retraction energy is accumulated inside of a hollow plunger rod
• CPC Class Codes: A61M 2005/5073 by breaking or rupturing the connection parts
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3234 Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An automatic mixing device, an actuating device removably mounted to the automatic mixing device and a retractable syringe having the automatic mixing device are provided. The actuating device has an initially compressed spring and a trigger member that initiates spring decompression to drive depression of a mixing plunger of the automatic mixing device. A seal located in the outer chamber is capable of axial movement upon depression of the mixing plunger, from a first position in sealing engagement with one or more apertures in an inner barrel to a second position intermediate the apertures and vents in an outer barrel. This allows depression of the mixing plunger to force a first substance from the outer chamber through the apertures to mix with a second substance in an inner chamber of the inner barrel. The mixed substance in the inner barrel is then delivered by the syringe with subsequent needle retraction.

Claims

1. A syringe having a longitudinal axis, the syringe comprising:

a delivery plunger; and

a needle;

an automatic mixing device including;

a mixing device including;

an inner barrel including a wall and defining an inner chamber, the delivery plunger being axially movable within the inner chamber;

an outer barrel in a substantially coaxial relationship with the inner barrel, the outer barrel defining an outer chamber radially between the outer barrel and the inner barrel;

a passage formed through the wall of the inner barrel and providing communication between the outer chamber and the inner chamber; and

a mixing plunger axially moveable within the outer chamber; and

an actuating device removably mounted to the mixing device, the actuating device including;

a housing releasably connected to the mixing device;

a trigger member configured in an initially locked state to the housing;

a sleeve engaged with the mixing plunger of the mixing device; and

a biasing member disposed in an energized state between the housing and the sleeve;

wherein the trigger member is rotatable around the longitudinal axis to unlock the trigger member from the housing to place the trigger member in an unlocked state, the trigger member being axially operable to release the biasing member to de-energize to axially move the mixing plunger within the outer chamber to thereby urge contents of the outer chamber through the passage into the inner chamber.

2. The syringe of claim 1, at least a first mixing substance being locatable in the outer chamber and at least a second mixing substance is locatable in the inner chamber.

3. The syringe of claim 1, wherein the passage includes one or more fluid paths.

4. The syringe of claim 1, further comprising a mixing plunger lock which prevents removal of the mixing plunger from the mixing device.

5. The automatic mixing device of claim 1, wherein in the initially locked state the housing comprises one or more lock members that initially engage one or more complementary locking channels in the trigger member, whereby rotation of the trigger member disengages the one or more lock members from the one or more complementary locking channels to thereby unlock the trigger member.

6. The syringe of claim 1, wherein the sleeve co-operates with the housing to maintain the biasing member in an initially energized state.

7. The syringe of claim 6, wherein the sleeve comprises one or more arms which releasably engage the housing to maintain the biasing member in an initially energized state.

8. The syringe of claim 7, wherein the trigger member is operable to release the arms from engagement with the housing to thereby de-energize the biasing member which forces the sleeve to move axially and bear against and depress the mixing plunger.

9. The syringe of claim 8, wherein the biasing member is a spring which is maintained in an initially compressed state, whereby decompression of the spring forces the sleeve to bear against and depress the mixing plunger.

10. The syringe of claim 8, wherein the sleeve includes guides and the housing comprises grooves that are engaged by said guides to guide axial movement of the sleeve.

11. The syringe of claim 3, which comprises one or more vents in the outer barrel.

12. The syringe of claim 11, wherein the one or more vents are operable to facilitate exit of air from the outer chamber to atmosphere when the mixing plunger is slidably moved in the outer chamber.

13. The syringe of claim 11, further comprising a distal seal initially in sealing engagement with said one or more fluid paths in the inner barrel.

14. The syringe of claim 13, wherein axial movement of the mixing plunger indirectly facilitates axial movement of the distal seal to a position intermediate or at least partly between said one or more fluid paths and said one or more vents.

15. The automatic mixing device of claim 13, which further comprises a removable safety cap having a plurality of protrusions which are insertable through respective said vents so as to be adjacent to, or in contact with, the distal seal.

16. The syringe of claim 1, which further comprises a proximal seal engaged, coupled, connected or affixed to the mixing plunger and slidably moveable in the outer chamber of the mixing device.

17. The syringe of claim 16, including a plurality of mixing substances including at least a first mixing substance, and wherein axial movement of the mixing plunger urges the first mixing substance into the inner chamber.

18. The syringe of claim 1, wherein the syringe is a retractable syringe and the needle is a retractable needle.

19. The syringe of claim 18, including the delivery plunger disposed in the inner chamber, wherein the delivery plunger is configured to engage and retract the needle.

20. The syringe of claim 19, comprising a second biasing member that is configured to retract the needle.

21. The syringe of claim 19, wherein the delivery plunger comprises a spring, a plunger member, a plunger outer and one or more locking members, the plunger member and plunger outer co-operating to releasably maintain said spring in an initially energized state, the syringe further comprising a needle assembly comprising the retractable needle, wherein the retractable needle comprises a cannula and a needle body engageable by the plunger member.

22. A method of assembling the syringe according to claim 1 including the step of removably mounting the actuating device to the mixing device of the syringe so that the actuating device is operable to depress the mixing plunger of the mixing device.

23. The method of claim 22, wherein the method includes the step of releasably connecting or coupling the housing of the actuating device to the outer barrel of the mixing device.

24. A method of operating the syringe according to claim 1 said method including the steps of:

(i) operating the actuating device of the automatic mixing device to facilitate mixing a plurality of substances; and

(ii) operating the delivery plunger to deliver the plurality of substances mixed in step (i) to a recipient.

25. The method of claim 24, which includes the step of removing the actuating device from the syringe between steps (i) and (ii).

26. The method of claim 25, which further includes the step of (iii) activating a needle retraction mechanism to retract the needle into the syringe.